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临床试验/NCT00932399
NCT00932399已完成不适用

Weight Change, Physical Activity and Health Promotion in Veteran Amputees

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 4,549 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,549
试验地点
1
主要终点
% Weight Change From Baseline

研究概览

简要总结

The purpose of this study is to assess weight change in a population of Veterans with amputations. Little is known about the how weight changes following an amputation. It is widely believed that many patients experience weight gain following amputation. This study aims to identify magnitude of weight changes following amputation and determine characteristics associated with weight gain. Information on weight change trajectories would be useful to better understand long-term health consequences associated with amputation and to design and target interventions to encourage weight maintenance and general health promotion for groups at high risk of weight gain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
27 Years 至 89 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • "Exposed" cohort:
  • incident lower limb amputation during the study period (1/1997-12/2008) in VISN 20
  • >= 1 plausible weight recoded in the medical record at baseline (defined as 8 weeks before amputation or 2-8 weeks post amputation)
  • >=1 weight measured post amputation (2 months to 42 months post amputation)
  • "Unexposed" (comparison) cohort:
  • no lower limb amputation during the study period
  • no prior history of amputation
  • >= 2 plausible recorded weights including at least one in the 2-6 weeks after their reference date ("baseline").
  • Alive at least 18 months after "baseline"

排除标准

  • female (due to small number of women with lower limb amputations)
  • lack information on any of the characteristics used for matching (e.g., birth year/age and height to calculate body mass index)

结局指标

主要结局

% Weight Change From Baseline

时间窗: At ~3 years after baseline

Time window for 3 years is 31-39 months after baseline

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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